Scars After Central Venous Catheters
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ClinicalTrials.gov Identifier: NCT01113125 |
Recruitment Status
: Unknown
Verified February 2014 by Mette Møller Handrup, Aarhus University Hospital.
Recruitment status was: Active, not recruiting
First Posted
: April 29, 2010
Last Update Posted
: February 12, 2014
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Most children with cancer need a central venous catheter. These catheters are typically placed on the anterior thorax, where the risk of hypertrophic scarring and keloid development is greatly enhanced. A significant part of the children who have survived childhood cancer are troubled by their scars.
Topical glucocorticoid treatment is known to induce a reduction of the collagen in the connective tissue.
The investigators hypothesize that treatment with topical glucocorticoids for one week before and three weeks after removal of a central venous catheter, will reduce the formation of hypertrophic scarring and keloid development in children.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertrophic Scars Keloids | Drug: Betamethason-17-valerate and fusidic acid Drug: Fusidic Acid | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children |
Study Start Date : | March 2010 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Fucicort |
Drug: Betamethason-17-valerate and fusidic acid
0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
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Placebo Comparator: Fucidin |
Drug: Fusidic Acid
0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
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- scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal [ Time Frame: Twelve months ]
- Judgement of the scar by Patient and observer scar scale after six months [ Time Frame: six months ]
- Judgement of the scar by Patient and observer scar scale after twelve months [ Time Frame: twelve months ]
- scars measured by the Vancouver Scar Scale six months after central venous catheter removal [ Time Frame: six months ]

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011
Exclusion Criteria:
- Known allergy towards plaster or fusidic acid

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113125
Denmark | |
Arhus University Hospital Skejby | |
Aarhus, Aarhus N, Denmark, 8200 |
Principal Investigator: | Henrik Hasle, Professor | Aarhus University Hospital Skejby |
Publications:
Responsible Party: | Mette Møller Handrup, MD, PhD, Aarhus University Hospital |
ClinicalTrials.gov Identifier: | NCT01113125 History of Changes |
Other Study ID Numbers: |
2009-015163-14 2009-015163-14 ( EudraCT Number ) 73191198 ( Other Identifier: Danish Medicines Agency ) 20090206 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics ) |
First Posted: | April 29, 2010 Key Record Dates |
Last Update Posted: | February 12, 2014 |
Last Verified: | February 2014 |
Keywords provided by Mette Møller Handrup, Aarhus University Hospital:
hypertrophic scar keloid central venous catheter children cancer |
Additional relevant MeSH terms:
Hypertrophy Keloid Cicatrix, Hypertrophic Pathological Conditions, Anatomical Collagen Diseases Connective Tissue Diseases Cicatrix Fibrosis |
Pathologic Processes Fusidic Acid Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |